Mr. Speaker, it is with pleasure that I speak to Bill C-307, the phthalate control act. The bill seeks to regulate the use of certain phthalates in products that Canadians may be exposed to.
I want to take this opportunity to thank all the members of the Standing Committee on the Environment and Sustainable Development for their hard work in reviewing this bill.
BillC-307, as amended by the committee, will ensure that the government takes the appropriate evidenced based approach to protect Canadians from exposures to levels of phthalates that can cause them harm.
The amended bill restricts the use of DEHP in children's toys, cosmetics and medical devices using the appropriate existing federal statutes and regulations.
Under the current regulatory regimes and in keeping with the federal constitutional jurisdiction, Health Canada has legislative authorities in place to regulate the safety and effectiveness of medical devices and their manufacturers under the Food and Drugs Act and the medical devices regulations.
One phthalate known as DEHP is used as a softening agent for many medical grade plastic materials made from polyvinylchloride, PVC.
Without a softening agent life saving medical devices such as medical tubing and blood bags would be brittle and crack during use, or could not be sterilized as effectively.
Alternative materials have been developed for use in some medical devices for certain medical applications. In other cases non-DEHP containing devices are not available or do not perform as well as devices made with DEHP.
In these cases an individual risk evaluation must be undertaken to fully understand the implications of alternate treatments or no treatment compared with the use of a medical device containing small quantities of DEHP.
Only a physician in consultation with the patient can make the final decision as to what is an appropriate medical treatment. No medical device or drug is 100% safe and effective. This is an important consideration in any decision when seeking medical treatment.
It follows then that the government's response to the phthalates in medical devices must differ from its approach taken with other consumer products.
Concerns have been raised about the safety of DEHP in medical devices since the 1980s. These concerns are based on studies showing that DEHP administered at high doses to rodents caused certain adverse effects, particularly effects on the developing reproductive system in young males.
There is concern that DEHP has the potential to produce similar adverse reproductive effects on humans, although there are no reliable data demonstrating that it does.
Health Canada has extensively studied the safety of DEHP in medical devices. In 2001 Health Canada completed a review of the scientific and medical literature and in the fall of 2001 convened an expert advisory panel to review the report and provide specific advice on managing the risk associated with the use of DEHP in medical devices. The recommendations of the advisory panel were made public in January 2002 and implemented.
In 2003 Health Canada published a draft position paper regarding the use of DEHP in medical devices. Health Canada has committed to finalize this position paper within the next few months.
Bill C-307, as amended in committee, recognizes that it is not in the best interests of Canadians to ban all medical devices containing DEHP in Canada at this time because alternate treatment options may not exist; and secondly, alternate treatment options may present higher risks to the patients.
Bill C-307 will aim to provide Canadians with continued access to needed medical devices, such as blood bags and intravenous tubing, when DEHP-free devices are not available or appropriate.
Under this bill the Government of Canada will work with the health care community, hospital associations, industry and other stakeholders to facilitate the development and promotion of clinical practice guidelines for the use of DEHP-containing medical devices. It will finalize and release a position paper on the use of medical devices containing DEHP and develop a guidance document on labelling requirements for these products.
The government will also give priority to the review of phthalate-free medical devices intended to be used on vulnerable patient groups. These actions will lead to a phase-out of the use of DEHP in medical devices starting with those used on vulnerable populations such as children, pregnant women and newborns.
This approach will aim to provide Canadians with continued access to the best available medical devices and treatment options. Health Canada continues to monitor and review the approaches of other global regulatory agencies with regard to the potential risks associated with DEHP and other phthalates used in medical devices.
Since the 1980s' Canada's risk management approach to this subject has been evidence based, recognizing the balance between potential exposure to DEHP with the need for medically necessary treatments.
I can assure members that Canada's approach to minimize the risk associated with medical devices containing DEHP is one of the most stringent in the world. I would also urge members to support Bill C-307 as amended by the committee and proposed actions by Health Canada and Environment Canada aimed to ensure the health and well-being of Canadians.
I would like to take a moment to reflect on the hard work of the Parliamentary Secretary to the Minister of the Environment, the member for Langley, and his lead at the environment committee. We all know that can be a very challenging position. The member for Langley has demonstrated that the committee process is active and well through the cooperation of the mover of the bill and others to demonstrate that this Parliament is in fact working.
As I mentioned previously, Bill C-307 was amended at committee to make sure that we clearly reflect the realities in the medical community. Medical devices are very important. On one hand we want them to be available; however, as I said, there are always risks with some devices. I think the committee has struck a balance. The Parliamentary Secretary to the Minister of the Environment should be congratulated for navigating this bill through the committee.
I think Canadians, in particular vulnerable Canadians such as children, pregnant women and newborns, will be better off for the hard work of the committee, and particularly the member for Langley, the Parliamentary Secretary to the Minister of the Environment.